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Sponsored by: |
Lund University Hospital |
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Information provided by: | Lund University Hospital |
ClinicalTrials.gov Identifier: | NCT00658268 |
The primary focus of this study is to investigate whether increased bone density of the graft in revision arthroplasty of the hip can cause a decreased micromotion of the implant relative to the femur.
Condition | Intervention | Phase |
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Aseptic Loosening of the Hip Prosthesis |
Drug: Clodronate Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Bisphosphonates and Impaction Grafting in Hip Revision Evaluated With Radiostereophotogrametri. A Randomized, Double-Blind Study in Patients Operated for Aseptic Loosening and Osteolysis. |
Estimated Enrollment: | 32 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Clodronate
60 mg/ml, 10 ml, single dose mixed in bone graft at operation
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2: Placebo Comparator |
Drug: Placebo
10 ml, single dose mixed in bone graft at operation
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Morsellized compacted bone allograft can be used for revision arthroplasty of the hip. Treating the graft locally with an antiresorptive substance such as a bisphosphonate has decreased the graft resorption in animal studies and led to a remained bone density in a human series of 16 patients. In the present study we investigate if this increased bone density of the graft also causes a decreased micromotion of the implant relative the femur. 36 patients are planned to participate in a 1:1 randomized and prospective study comparing the bisphosphonate Clodronate to saline. Primary outcome will be micromotion over the first year but also secondary parameters such as late micromotion (between 12 and 24 months), re-loosening subjective outcome and safety. We hypothesize that rinsing the graft in a bisphosphonate solution prevents its resorption and therefore may reduce the risk of mechanical failure.
Patients are followed with radiograms, RSA (radiostereography) preop, postop, at 6 weeks, at 12 and 24 months and subjective months and subjective parameters including Womac and SF 12. The treatment is simple, cheap and appears virtually risk-free.
Ages Eligible for Study: | 45 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Magnus Tagil, MD, PhD | 46-46-171-501 | magnus.tagil@med.lu.se |
Sweden | |
Lund University Hospital | Recruiting |
Lund, Sweden, SE-22185 | |
Contact: Magnus Tagil, MD, PhD 46-46-171-000 magnus.tagil@med.lu.se | |
Principal Investigator: Magnus Tagil, MD,PhD |
Principal Investigator: | Magnus Tagil, MD, PhD | Department of Orthopaedics, Lund University Hospital,Lund, Sweden |
Responsible Party: | Dept of Orthopaedics, Lund University Hospital ( Per Gustafson, MD, PhD ) |
Study ID Numbers: | NKOISR10001, EudraCT2006-006439-39 |
Study First Received: | April 9, 2008 |
Last Updated: | April 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00658268 History of Changes |
Health Authority: | Sweden: The National Board of Health and Welfare |
Surgical procedures operative Prosthesis implantation Arthroplasty replacement |
Clodronic Acid Osteolysis Diphosphonates Bone Density Conservation Agents |
Clodronic Acid Diphosphonates Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |